《遺尿癥中藥臨床試驗設計與評價技術指南》為中華中醫(yī)藥學會標準化項目《兒科系列常見病中藥臨床試驗設計與評價技術指南》之一。其目的是以臨床價值為導向，主要是在病證結合模式下，重點討論具有遺尿癥疾病、兒童和中藥特點的臨床定位、試驗設計與實施等相關問題，為中藥治療兒童遺尿癥臨床試驗設計與評價提供思路和方法。制定過程中先后成立指南工作組、起草專家組和定稿專家組，采用文獻研究和共識會議的方法，最終形成指南送審稿定稿。該指南的主要內(nèi)容包括臨床定位、試驗總體設計、診斷標準與辨證標準、受試者的選擇與退出、治療觀察方法、試驗流程、有效性評價、安全性觀察、試驗的質量控制、倫理學要求10部分，以期為申辦者或合同研究組織、研究者在兒童遺尿癥中藥臨床試驗及上市后臨床有效性再評價方案設計中提供借鑒與參考。

Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases: Nocturnal Enuresis is one of the standardization projects of the China Association of Traditional Chinese Medicine Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases. The purpose is to discuss the clinical positioning, experimental design and implementation of the characteristics of nocturnal enuresis, children and traditional Chinese medicine under the mode of combining disease and syndrome with clinical value, so as to provide suggestions and methods for the design and evaluation of clinical trial of nocturnal enuresis with traditional Chinese medicine. In the process of developing, working group on the guidelines, drafter group and a finalizer group were established, and the methods of literature research and consensus meeting were adopted to form the final draft of the guidelines. The main contents of this guideline include clinical positioning, overall design of the trial, diagnostic and syndrome differentiation criteria, selection and withdrawal of subjects, therapeutic observation methods, trial process, effectiveness evaluation, safety observation, quality control of the trial and ethics requirements. The formulation of this guideline provides references for the sponsor or contract research organizations and researchers to design clinical trials and postmarketing evaluation on the treatment of nocturnal enuresis with traditional Chinese medicine.

R287.5;R288.1

重大新藥創(chuàng)制項目"兒童中藥新藥臨床評價技術示范性平臺建設"(2020ZX09201-008)